Minnesota State Regulatory Update April 2019
CBD products derived from industrial hemp and intended for human consumption are drugs, as defined in Minnesota Statute 151.01, Subdivision 5.
Under Minnesota law, drugs are misbranded and adulterated if: they are not approved for medical use by FDA; their labeling has not been approved by FDA; they are not manufactured at a facility registered by FDA and licensed by the Board; or they are not manufactured using cGMPs. From the labeling of some CBD products, they are intended to affect the structure or function of the bodies of humans and animals.
Any products, other than a food product, that make such claims fall under the legal definition of the word "drug". And if the products are drugs, their sales are illegal under Minnesota Statute 151.34.
The sale of most products that contain CBD extracted from any type of cannabis plant and intended to be used to treat medical conditions or to alter the structure and function of human or animal bodies, remains illegal under both federal and state law. The exceptions would be FDA-approved drugs, such as the recently approved Epidiolex, and the products allowed to be sold under state law by the manufacturers that are regulated by the Minnesota Department of Health, Office of Medical Cannabis.
What does this mean to pharmacists practicing in the state of Minnesota?
- Pharmacists cannot sell any products containing CBD, hemp, or any derivative that are classified as a drug by the Board of Pharmacy. The only exemptions are those products approved by the FDA or regulated by the state of Minnesota DOH. Ensure that none of these products are represented for sale in your pharmacy.
Minnesota State Regulatory Summary- 2018
The following laws, summarized below, were enacted by the Minnesota legislature during the 2018 session:
SF3480 Disclosure for Payment of Healthcare Services Effective July 1, 2019
A healthcare provider is obligated to provide a good-faith estimate to a consumer of the anticipated costs for services, including total cost and patient responsibility. No healthcare plan contract can prohibit a provider (defined as a primary care provider) from providing this information to the consumer.
HF 3196 Step Therapy Protocol and Establishment of Overrides for Prescription Drug Coverage Established - Effective July 1, 2019
A health plan shall consider available recognized evidence-based and peer-reviewed clinical practice guidelines when establishing a step therapy protocol.
What do these new regulations mean for pharmacists practicing within the state of Minnesota?
- While the regulations do not directly affect or require additional work on the part of the pharmacist, these can help the pharmacist assist the patient in gaining resolution for rejected prescriptions when associated with an approved step therapy protocol.
For full regulatory language, refer to the Minnesota Board of Pharmacy.
